Human Subjects Protection Scientist

Human Subjects Protection Scientist

Job Description

General Dynamics Information Technology – Health and Civilian Solutions Division is currently looking for a Human Subjects Protection Scientist to join our team to support our client at the Office of Research Protection - MRMC. This position is based in Ft. Detrick – Frederick, Maryland.

Provide regulatory-based written review of protocol life cycle actions using standardized checklists.

Delineate deficiencies and areas of noncompliance and makes recommendations to the HRPO federal AAs regarding regulatory and ethical issues in HRPO post-approval submissions.

Provide a comprehensive review and evaluation of protocol amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse event, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports and provide a professional quality written review, as required.

Support the HRPO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols. The contractor shall provide regulatory-based written review of HRPO reportable events. Support includes preparing, planning, conducting, and reporting on compliance inspections of research for which HRPO has oversight.

Assist in the preparation of the written report of each compliance inspection that includes, but is not limited to, written specific findings of the inspection and recommendations that would enable the institution to bring the research into compliance.

Provide support for the HRPO transition from paper to electronic review processes, including implementation and training on electronic review processes.

Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the USAMRMC.

Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines.

Interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and HRPO requirements.

Participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing HRPO standard operating procedures and work instructions.

Education

Bachelors Degree in a scientific discipline.

Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred but not essential.

Qualifications

Must possess a working knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for HQ USAMRMC review and oversight (essential).

Working knowledge of ethical principles related to participation of humans in research (essential).

Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review.

Demonstrate ability to use all components of Microsoft Office and to write clear, precise, detailed, comprehensive and grammatically correct memos and technical reports (absolute requirement).

Company Description

General Dynamics is a global aerospace and defense company. From Gulfstream business jets to submarines to wheeled combat vehicles to communications systems, people around the world depend on our products and services for their safety and security. Headquartered in Falls Church, Virginia, General Dynamics is led by Phebe Novakovic. The company employs thousands of people, with locations in 43 countries. At the heart of our company are our employees. We rely on their intimate knowledge of customer requirements and a unique blend of skill and innovation to develop and produce the best possible products and services.The driver that makes our company agile, and ensures our continued performance, is our culture of continuous improvement. This culture enforces a shared commitment to consistently look toward the future and to embrace change.